Cited by 46Fault Detection and Control SystemsSpectroscopy and Chemometric AnalysesViral Infectious Diseases and Gene Expression in Insects

Multivariate data analysis on historical IPV production data for better process understanding and future improvements

Thomassen, Yvonne E., van Sprang, Eric N.M., van der Pol, Leo A., Bakker, Wilfried A.M.·2010·Biotechnology and Bioengineering

Abstract

Historical manufacturing data can potentially harbor a wealth of information for process optimization and enhancement of efficiency and robustness. To extract useful data multivariate data analysis (MVDA) using projection methods is often applied. In this contribution, the results obtained from applying MVDA on data from inactivated polio vaccine (IPV) production runs are described. Data from over 50 batches at two different production scales (700-L and 1,500-L) were available. The explorative analysis performed on single unit operations indicated consistent manufacturing. Known outliers (e.g., rejected batches) were identified using principal component analysis (PCA). The source of operational variation was pinpointed to variation of input such as media. Other relevant process parameters were in control and, using this manufacturing data, could not be correlated to product quality attributes. The gained knowledge of the IPV production process, not only from the MVDA, but also from digitalizing the available historical data, has proven to be useful for troubleshooting, understanding limitations of available data and seeing the opportunity for improvements.

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Crossref · 10.1002/bit.22788

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Authors
Thomassen, Y. E., van Sprang, E. N. M., van der Pol, L. A., & Bakker, W. A. M.
Corresponding author
Thomassen, Yvonne E.
Venue
Biotechnology and Bioengineering
Publisher
Wiley
Published
2010-06-11
Volume
107
Issue
1
Pages
96-104
ISSN
  • 0006-3592 (ISSN-L)
  • 1097-0290
OpenAlex
W1995581041
Cited by
46
References
20
Citations by year
2026: 1 · 2025: 1 · 2024: 2 · 2023: 2 · 2021: 2 · 2020: 3 · 2019: 3 · 2017: 2 · 2016: 5 · 2015: 4 · 2014: 4 · 2013: 7 · 2012: 3
FWCI
9.01
Type
journal article
Language
en
Open access
closed
Locations
  • Biotechnology and Bioengineering (publishedVersion)
  • PubMed (publishedVersion)
  • Rivm (National Institute for Public Health and the Environment) (submittedVersion)
Topics
  • Physical Sciences › Engineering › Control and Systems Engineering › Fault Detection and Control Systems
  • Physical Sciences › Chemistry › Analytical Chemistry › Spectroscopy and Chemometric Analyses
  • Life Sciences › Biochemistry, Genetics and Molecular Biology › Molecular Biology › Viral Infectious Diseases and Gene Expression in Insects
Keywords
inactivated poliovirus vaccine, vaccine production, multivariate analysis, principal component analysis, outlier detection, process variation, process understanding, process optimization, troubleshooting
MeSH terms
Animals, Chlorocebus aethiops, Data Interpretation, Statistical, Forecasting, Industry, Models, Biological, Poliovirus Vaccine, Inactivated, Vero Cells, Multivariate Analysis

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